D-1082-2015 Class II Terminated
FDA drug recall D-1082-2015 was initiated by Alvogen, Inc on April 21, 2015 and is designated Class II. Reason for recall: Failed Dissolution Specification; 6 month time point The recall status is terminated (terminated December 4, 2015). Affected quantity: 13,392 bottles (100 count).
Recall Details
- Product Type
- Drugs
- Report Date
- May 20, 2015
- Initiation Date
- April 21, 2015
- Termination Date
- December 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,392 bottles (100 count)
Product Description
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Reason for Recall
Failed Dissolution Specification; 6 month time point
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 457529, exp. 08/2016